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JOBS - Clinical Research
There are currently 5 jobs listed in this category (displaying 1 to 3).
Clinical Protocol Manager
Location: Connecticut
Job Description
Drives the successful and timely execution of a clinical protocol(s) from study start up to final clinical study report within established budget. Leads the Indication/Protocol Team using interpersonal and project management skills. Coordinates and drives all activities of the Protocol Team through the functional management of the team. Demonstrates a strong understanding of the overall development program of the molecule; the indication studied; and the purpose and design of the assigned protocol(s) consistent with the BMS SOPs and business practices. Monitors protocol progress using the available management tools guiding next steps and taking necessary action to prevent or address problems regarding timelines, budget, resources and quality. Reviews protocol data to monitor for safety issues. Coordinates and/or participates in the following activities but not limited to: country and site selection, Investigator meetings, CRF building, building data review plans, database validations, listing requirements and review, monitoring set start up, monitoring patient recruitment, preparation and/or review of appropriate clinical and regulatory documents, medication/material/CRF distribution, timely data collection, delivery of final database. Manages clinical component of vendor selection and acts as the central point of contact for communication between the team and external partners if any (e.g. CRO, central labs, cooperative groups, alliance partners, etc.) Responsible for the management of all activities related to the contract deliverables of protocol(s) is applicable. Participates in the completion of documents for NDA/MAA filings and responses to health authorities. Negotiates protocol budgets, contracts and other study costs with sites and vendors as appropriate.
Job Requirements
Contributed to the successful execution of a protocol from study start to database lock. Experience in management of protocol activities associated with an international trial. Demonstrated effectiveness as mentor and leader in a clinical research setting. Proven teambuilding skills and ability to foster partnerships within projects and multidisciplinary teams. Effectively used oral and written communication skills to influence, inform and guide others.
Contact Information
Beverly Horvat
Senior Executive Recruiter
bhorvat@criticalpathinc.net
412-851-4144 X16
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Clinical Veterinarian...
Location: Connecticut
Job Description
Responsible for execution of the Program of Veterinary Care in WWCM (Worldwide Comparative Medicine). In this role, the individual will be responsible for delivering high quality veterinary care to diverse species of research animals. Additionally, will develop novel approaches to promote animal well-being and care, while preserving study endpoints.
Reports to the Director of Laboratory Animal Medicine and Surgery (LAMS). Will be expected to introduce new approaches, strategies and/or methodologies that improve productivity and regulatory outcomes. Will need to be able to engage other disciplines and subject matter experts for solving complex issues.
Collaborates with TA partners on animal model development/refinement within area of platform competency (e.g. cardiology, neurology, ophthalmology). Presents original work externally in venues relevant to area of expertise (e.g. AALAS, ACLAM, other scientific organizations).
Participates on LAMS Leadership team and establishes departmental objectives for the Program of Veterinary Care. Responsible for setting objectives, goals, and timelines for own projects and direct reports. Responsible for supervision and career development of veterinary technical colleagues.
Actively participates on WWCM teams in support of regulatory initiatives, operational, and scientific activities. Engages in departmental and site activities to contribute to corporate initiatives and as career development (e.g. Diversity).
Job Requirements
Required: DVM; licensed to practice in the US or equivalent ; Board eligible or certified by ACLAM (or equivalent). PhD with basic science research experience preferred.
Required: minimum 5 years laboratory animal medicine experience with record of increased responsibilities and accomplishments. Candidate must have excellent oral and written communication skills and be able to work effectively on multi-disciplinary teams.
Preferred: Pharmaceutical or other industry experience is desirable, as is experience working on research project teams.
Contact Information
To respond to this job contact:
Karen Baldwin
412-851-4144 x 12
kbaldwin@criticalpathinc.net
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Director, Global Clinical Research (Cardiovascular)
Location: New Jersey
Job Description
Directs the design, development and execution of the clinical drug development plans, protocols and related activities. Assures protocols will adhere to standard clinical practices. Secures the conditions essential for safety, efficiency and medical usefulness of a drug. Decides how the resulting data should be analyzed and interpreted. Recommends new approaches to data analysis and prep. Organizes meetings to discuss critical issues. Chairs and participates in project development teams. Coordinates with related functional areas of PRI.
Job Requirements
- MD
- Minimum of two years of relevant experience preferred.
- Must have demonstrated originality in problem solving as applied to drug development.
Contact Information
Karen Baldwin
kbaldwin@criticalpathinc.net
(412)851-4144 x: 12
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